BioSpectra is a US based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buyers and Solutions. Our focus is small molecule synthesis and true, phase change multistep purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DM submissions. All our manufacturing processes are fully validated. Our US-GMP regulatory package complies with USFDA, IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources. Our commitment is to quality, compliance and true, US-GMP manufacturing with unparalleled regulatory support. We own and operate out of ~343,000 square feet of FDA registered & inspected GMP manufacturing and warehouse space, operating under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to key ingredient issues our customers may have. BioSpectra operates out of 52 acres of land in 6 Municipalities of Pennsylvania and New York. This includes an FDA Registered, Bulk Chemical, Premium Pharmaceutical Ingredient manufacturing facility in Bangor, PA, an FDA Registered, Bulk Chemical, Biological Buffer manufacturing facility in Stroudsburg, PA and a cMP Kilo-Scale manufacturing facility in Rensselaer, NY. The Organization also owns and operates a Corporate Center facility in Wind Gap, PA, a Supply Chain facility in Stroudsburg, PA, and a Fleet Management facility in Bangor, PA. The Organization employs approximately 300 people.

History

  • The BioSpectra Organization was created on December 26, 1993 operating from offices near Shawnee on the Delaware. BioSpectra, Inc. (BSI) was first incorporated in Pennsylvania, USA, on September 15, 1995.
  • The Original BioSpectra operated from a site in Sciota, PA., manufacturing reagent grade buffers and laboratory chemicals.
  • In 2001, BS opened the Stroudsburg, Rockdale Lane facility and creating the first fully dedicated second facility for the production of repurified MP Biological Buffers that changed the scale of available cGMP Biological Buyers to the BioPharma Industry.
  • In 2006, BSI created BioBuffer Solutions Brand to support the need for upstream materials to our critical customers. That Brand will undergo further expansion at a new facility in 2024/2025.
  • In 2011, BS acquired the much larger, Bangor, PA facility to expand manufacturing and expand our portfolio of GMP Pharmaceutical Process Fine Chemicals, Excipients and API's.
  • In 2019 and 2020 we acquired several other local properties to house external services such as our Fleet of cars and trucks, building and ground equipment and non-controlled storage).
  • In April of 2021 BSI opened our Corporate Services Center in Wind Gap PA.
  • Also, in 2021, renovation work began on our Kilo GMP Facility in Rensselaer NY which is now known as BDI (BioDevelopment Inc).
  • More recently in January of 2023 we opened our 60,000 square foot GMP storage facility at 3rd Street in Stroudsburg PA, while simultaneously officially opening our Kilo MP Scale facility in Rensselaer NY.
  • And we are not done! We are busy working to expand our manufacturing footprint overseas as well and in 2024/2025 plan to open another 80,000 square foot facility adjacent to our GMP Storage facility to house our expanding analytical services and automated packaging operations.